A Pilot Study of BMS-512148 in Subjects With Type 2 Diabetes
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00357370
First received: July 26, 2006
Last updated: September 10, 2010
Last verified: July 2009
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Purpose
The purpose of this clinical research study is to learn if BMS-512148, added to insulin and one or two anti-diabetes medications (metformin and/or pioglitazone or rosiglitazone), can help reduce the blood sugar levels compared to insulin and one or two anti-diabetes medications (metformin and/or pioglitazone or rosiglitazone) alone, in subjects with type 2 diabetes. The safety of this treatment will also be studied.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes |
Drug: Dapagliflozin Drug: Placebo |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Pilot Study of the Efficacy and Safety of BMS-512148 on Glycemic Control in Subjects With Type 2 Diabetes Treated Aggressively But Not Controlled on Combination Antihyperglycemic Therapy With Metformin and/or Thiazolidinedione (TZD) and Insulin. |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- Change from baseline in hemoglobin A1C [ Time Frame: at Week 12 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change from baseline in fasting plasma glucose [ Time Frame: at Week 12 ] [ Designated as safety issue: No ]
- Change from baseline in the proportion of subjects achieving therapeutic glycemic responses [ Time Frame: at Week 12 ] [ Designated as safety issue: No ]
- Change from baseline in the total daily dose of insulin [ Time Frame: at Week 12 ] [ Designated as safety issue: No ]
| Enrollment: | 67 |
| Study Start Date: | October 2006 |
| Study Completion Date: | March 2008 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Cohort 1
20 mg
|
Drug: Dapagliflozin
Tablets, Oral, once daily, up to 12 weeks
Other Name: BMS-512148
|
|
Experimental: Cohort 2 - Arm 1
10 mg
|
Drug: Dapagliflozin
Tablets, Oral, once daily, up to 12 weeks
Other Name: BMS-512148
|
|
Experimental: Cohort 2 - Arm 2
20 mg
|
Drug: Dapagliflozin
Tablets, Oral, once daily, up to 12 weeks
Other Name: BMS-512148
|
| Placebo Comparator: Cohort 2 - Arm 3 |
Drug: Placebo
Tablets, Oral, 0 mg, once daily, up to 12 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Males and females, 18 to 75 years old, with type 2 diabetes with inadequate glycemic control
- Subjects receiving insulin and metformin and/or a thiazolidinedione
- Body Mass Index <=45.0 kg/m2
- Serum creatinine <1.5 mg/dL for men or <1.4 mg/dL for women
- No overt proteinuria (in subjects with a microalbumin/creatinine ratio ≥300 mg/g, the 24-hour urinary excretion of total protein must be <3 g/24 hrs)
Exclusion Criteria:
- History of type 1 diabetes
- AST and/or ALT >2.5 times the upper limit of normal
- Creatinine kinase ≥3 times the upper limit of normal
- Symptoms of severely uncontrolled diabetes
- History of hypoglycemic unawareness
- Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00357370
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Hide Study LocationsLocations
| United States, Arkansas | |
| Nea Clinic | |
| Jonesboro, Arkansas, United States, 72401 | |
| United States, California | |
| Valley Research | |
| Fresno, California, United States, 93720 | |
| Bernstein, Richard | |
| Greenbrae, California, United States, 94904 | |
| United States, Florida | |
| Jacksonville Center For Clinical Research | |
| Jacksonville, Florida, United States, 32205 | |
| United States, Georgia | |
| Endocrine Research Solutions, Inc. | |
| Roswell, Georgia, United States, 30076 | |
| United States, Indiana | |
| Indiana University | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Maryland | |
| Model Clinical Research Llc | |
| Baltimore, Maryland, United States, 21204 | |
| United States, Michigan | |
| University Of Michigan | |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, Missouri | |
| St. Louis Center For Clinical Research | |
| St. Louis, Missouri, United States, 63128 | |
| United States, New York | |
| Suny Upstate Medical University | |
| Syracuse, New York, United States, 13210 | |
| United States, North Carolina | |
| Mountain Diabetes And Endocrine Center | |
| Asheville, North Carolina, United States, 28801 | |
| United States, Ohio | |
| Your Diabetes Endocrine Nutrition Group | |
| Mentor, Ohio, United States, 44060 | |
| United States, Texas | |
| Research Institute Of Dallas, P.A. | |
| Dallas, Texas, United States, 75231 | |
| Diabetes And Glandular Disease Research Associates, P.A. | |
| San Antonio, Texas, United States, 78229 | |
| United States, Washington | |
| Rainier Clinical Research Center | |
| Renton, Washington, United States, 98055 | |
| United States, Wisconsin | |
| Advanced Healthcare S.C. | |
| Milwaukee, Wisconsin, United States, 53209 | |
| Canada, Manitoba | |
| Local Institution | |
| Winnipeg, Manitoba, Canada, R3E 3P4 | |
| Canada, New Brunswick | |
| Local Institution | |
| Bathurst, New Brunswick, Canada, E2A 4X7 | |
| Canada, Quebec | |
| Local Institution | |
| Gatineau, Quebec, Canada, J8V 2P5 | |
| Local Institution | |
| Laval, Quebec, Canada, H7T 2P5 | |
| Local Institution | |
| Longueuil, Quebec, Canada, J4N 1L6 | |
| Local Institution | |
| Pointe-Claire, Quebec, Canada, H9R 4S3 | |
| Local Institution | |
| Sherbrooke, Quebec, Canada, J1G 5K2 | |
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided
| Responsible Party: | Study Director, Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00357370 History of Changes |
| Other Study ID Numbers: | MB102-009 |
| Study First Received: | July 26, 2006 |
| Last Updated: | September 10, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013